System and method for tracking and regulating removal of patient medications

ABSTRACT

A pill packet dosage tracking and gating device is provided. The device includes a container, a gate, and a controller. The container includes a reservoir configured to hold a stream of pill packets and an extraction channel configured to guide the passage of the stream of pill packets from the reservoir out of the container. The gate is disposed in the extraction channel and is configured to vertically transition from a closed position blocking extraction of a pill packet of the stream of pill packets and an open position allowing extraction of a pill packet. The controller is configured to monitor the extraction of pill packets and control the transition of the gate from the closed position to the open position.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority to, and the benefit of, U.S.Provisional Application No. 62/832,089 filed Apr. 10, 2019 for allsubject matter contained in said application. The disclosure of saidpatent application is hereby incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to tracking and control of complexmedication regimens and/or safe removal of medications with serious sideeffects, abuse or diversion potential suitable for use in patients'homes, nursing homes, or Assisted Living Facilities. Use of theinvention facilitates increased medication adherence, monitoring of sideeffects, and enables use of specialized medications outside costlyhospital settings or doctors' offices. In particular, the presentinvention provides a solution for a low cost, controlled, and monitoredadministration of pills and capsules.

BACKGROUND

Patients prescribed more than five separate medications have an averageadherence to prescribed dosage and frequency of only 40%. Currently,more than 25 million Americans fall into this category, including thosewith costly chronic illnesses such as heart failure, cancer onchemotherapy, organ transplantation requiring immunosuppression, mooddisorders, and multi-illness co-morbidities. Based on agingdemographics, this number is estimated to rise to 40 million by 2025.

Failure to take medications as prescribed within a complex regimen leadsto deterioration in health, visits to emergency rooms, and preventablehospitalizations.

Furthermore, there is an epidemic of opioid abuse in the US,conservatively estimated to add $70B in cost to the healthcare system,creating incalculable suffering and death. Other medications subject toabuse are psychostimulants used to treat attention deficit hyperactivitydisorder (ADHD), vigilance enhancers for severe sleep disorders, andbenzodiazepine anxiolytics.

Packaging drugs for convenience in the form of a linear roll of pouches,blisters or sachets has been in use in many European countries for morethan ten years. More recently in the US, a large mail-order pharmacy hascoupled automated loading and inspection of sachets or packets holdingmultiple tablets and capsules with distribution of a linear spool oftime labeled doses within a cardboard, passive, container (e.g.,PillPack®). Similar packing technology is utilized by ExactCare® and CVSCaremark™.

While packaging multiple medications in sachets, packets or pouches fordosing limits the need for the patient to deal with a plethora ofbottles or vials containing single medications, the task of manuallypulling a varying number of packets or pouches to achieve, for example,doses of greater than 15 pills at some time points, presents a dauntingtask for patients on complex regimens. This is especially the case forpatients with mild cognitive impairment, a diagnosis with increasedprevalence among the elderly.

Furthermore, in the absence of monitoring, patients can omit doses or,by pulling the wrong number of pouches, take the following series oftime sensitive pills at inappropriate times, creating propagating errorsin adherence.

Moreover, in the absence of a security system, distributing medicationssuch as opioids in a roll of sachets does not prevent overuse by thepatient, illicit diversion, or theft of significant quantities ofabusable drugs.

SUMMARY

There is a need for systems and methods to raise adherence among thesecomplex patients, greatly improving their quality of care whilesubstantially reducing its cost. The present invention addresses theseneeds, in addition to other improvements and patentable characteristics.Unlike conventional devices and systems, the present invention does notrequire specialized labeling or barcoding initiated by a particularpharmacy system. The system has no motor-powered mechanisms for pushingor advancing dose units, thereby reducing failure modes, increasingreliability, and reducing cost.

As such, the present invention provides a low-cost accessory, usablewith a broad array of pill packets such as linear strips of pouches,packets, sachets, or blisters, which addresses both of the problemsabove, thereby simultaneously addressing the need to safely administerthese medications, reduce abuse which often leads to addiction, anddeter illicit diversion of medication.

In accordance with embodiments of the present invention, a pill packetdosage tracking and control device is provided. The device includes acontainer, a gate, and a controller. The container includes a reservoirconfigured to hold a stream of pill packets and an extraction channelconfigured to guide the passage of the stream of pill packets from thereservoir out of the container. The gate is disposed in the extractionchannel and is configured to vertically transition from a closedposition blocking extraction of a pill packet of the stream of pillpackets and an open position allowing extraction of a pill packet. Thecontroller is configured to monitor the extraction of pill packets andcontrol the transition of the gate from the closed position to the openposition.

In accordance with aspects of the present invention, the stream of pillpackets comprises one or more packet containing a predetermined dosageof pills wherein each pill packet is detachably connected to the nextpill packet in the stream. In certain aspects, the stream of pillpackets is provided in a roll for easy loading into the reservoir of thecontainer to be extracted—through the extraction channel.

In accordance with aspects of the present invention, the containerfurther comprises an upper shell and a lower shell wherein removing theupper shell provides access to the reservoir and extraction channel.

In accordance with aspects of the present invention, the gate includesan inner slider, and outer slider, an electric motor, and a linkage. Theouter slider is slidably coupled to the inner slider and has anengagement edge for engaging the stream of pill packs. The motor is usedto position the gate but not advance pouches. The linkage connects themotor to the inner slider and converts the rotational movement of themotor to the linear movement of the gate. In certain aspects, the gateis mechanically biased in a closed position by springs between the innerslider and outer slider. In some aspects, the gate further includes areceiver configured to receive the engagement edge of the outer sliderwhen the gate in a closed position. In still other aspects, theengagement edge of the outer slider has an asymmetrical shape such as aguillotine blade configuration.

In accordance with aspects of the present invention, the extracting ofpill packets through the extraction channel causes the gate totransition from a closed position to an open position indicating to thecontroller that a pill pouch has been extracted.

In accordance with aspects of the present invention, the controller isconfigured to maintain a count of pill packet extracted from device. Inother aspects, the controller is configured to detect the extraction ofone or more pill packets corresponding to a timed dosage and lock thegate in a closed position until the next timed dosage.

In accordance with aspects of the present invention, the controllerincludes a processor and one or more sensors. The processor isconfigured to monitor and control the gate and thus the extraction ofpill packets. The one or more sensors are configured to detect theposition of the gate. In certain aspects the controller also includeswireless connectivity. In some such aspects, the wireless connectivitycan be used to control the device remotely.

In accordance with aspects of the present invention, the device furtherincludes a display mounted on the container providing the status of thedevice. In some such aspects, the display is a touch screen display.

In accordance with aspects of the present invention, the device furtherincludes a sensor disposed along the extraction channel configured todetect a pill packet. In some aspects, the sensor is an optical scanner.In other aspects, the sensor is a camera.

In accordance with aspects of the present invention, the device may bein communication with an authorization device that indicates to thecontroller whether a pill pouch can be extracted.

BRIEF DESCRIPTION OF THE FIGURES

These and other characteristics of the present invention will be morefully understood by reference to the following detailed description inconjunction with the attached drawings, in which:

FIG. 1 depicts a perspective view, a side view, and a front view of thepill packet dosage tracking device in accordance with embodiments of thepresent invention;

FIG. 2 depicts the loading of a stream of pill packets into the pillpacket dosage tracking device in accordance with embodiments of thepresent invention;

FIG. 3 is an exploded perspective view of the pill packet dosagetracking device in accordance with embodiments of the present invention;

FIG. 4 is an exploded perspective view of the gate of pill packet dosagetracking device in accordance with embodiments of the present invention;

FIG. 5 depicts a controller of the pill packet dosage tracking device inaccordance with embodiments of the present invention;

FIG. 6 is a side view of the gate of pill packet dosage tracking devicein a closed position in accordance with embodiments of the presentinvention;

FIG. 7 is a side view of the gate of pill packet dosage tracking devicetransitioning to an open position around a pill packet in accordancewith embodiments of the present invention;

FIG. 8 is a transparent front view of the pill packet dosage trackingdevice showing the interaction of the elements of the gate in a closedposition in accordance with embodiments of the present invention;

FIG. 9 is a transparent front view of the pill packet dosage trackingdevice showing the interaction of the elements of the gate in an openposition in accordance with embodiments of the present invention;

FIG. 10 is a transparent perspective view of the pill packet dosagetracking device showing a sensor used to detect the position of the gatein accordance with embodiments of the present invention;

FIG. 11 depicts a communication networks showing the connectivity of thepill packet dosage tracking device in accordance with embodiments of thepresent invention; and

FIG. 12 is a diagrammatic illustration of a computing device and relatedhardware for use in implementation of the present invention.

DETAILED DESCRIPTION

An illustrative embodiment of the present invention relates to a systemand method for tracking of patient medication removal.

FIG. 1 through FIG. 12 are diagrammatic illustrations of an embodimentof the present invention in the form of an accessory to a stream ofpackets, pouches, or sachets (such as those packets, pouches, or sachetsprepared by Parata Pharmacy Robotics and distributed by PillPack, Inc.or ExactCare Pharmacy). The invention includes a container into whichthe pill packet stream is loaded. The patient actively participates indosing by pulling the pill packets through a gate.

In terms of behavioral psychology first established by B. F. Skinner,the patient's removal of pouches following a reminding signalconstitutes Operant Behavior, subject to increased frequency by areinforcer. This distinguishes the device from motorized dispenserswhich do not rely on the patient emitting a response.

The pill packet stream can move freely or be braked under mechanizedcontrol to indicate to the patient that they have withdrawn their fulldose of packets at the appropriate time. An indicator can be displayedon the device or auditory instructions from this or another device suchas a home voice assistant may aid the patient. The gate operates inresponse to a signal from a controller embedded in the device, or froman external device such as, a smart phone, tablet, or computer capableof Internet connectivity, and/or biometric verification or transmissionof its GPS coordinates.

FIG. 1 through FIG. 12, wherein like parts are designated by likereference numerals throughout, illustrate an example embodiment orembodiments of a system and method for tracking of pill packmedications, according to the present invention. Although the presentinvention will be described with reference to the example embodiment orembodiments illustrated in the figures, it should be understood thatmany alternative forms can embody the present invention. One of skill inthe art will additionally appreciate different ways to alter theparameters of the embodiment(s) disclosed, such as the size, shape, ortype of elements or materials, in a manner still in keeping with thespirit and scope of the present invention.

The system of the present invention can utilize data describing the timeof dosing of the patient's regimen, from which the number of pouchesrequired at each dose time is readily determined. These data could besupplied by the dispensing pharmacy, kept in a Health InsurancePortability and Accountability Act (HIPAA) secure format for access overthe world wide web or Internet, or provided on the packaging of thestream of pill packets or the pill packets themselves. Once obtained thedata can be stored locally on the device.

As shown in FIGS. 1 through 11, a pill packet dosage tracking device 100is provided. The device includes a container 102, a gate 104, and acontroller 106. The container includes a reservoir 108 configured tohold a stream of pill packets 110 and an extraction channel 112configured to guide the passage of the stream of pill packets 110 fromthe reservoir 108 out of the container 102. The gate 104 is disposed inthe extraction channel 112 and is configured to vertically transitionfrom a closed position blocking extraction of a pill packet 114 of thestream of pill packets 110 and an open position allowing extraction of apill packet 114. The controller 106 is configured to monitor theextraction of pill packets 114 and control the transition of the gate104 from the closed position to the open position.

FIG. 1 provides a perspective view, a side view, and a front view of thecontainer 102 providing an example of the dimensions for the container102 of the device 100. The extraction channel 112 can also be seen inthe front face of the container 102. In this example, the container 102is formed of an upper shell 116 and a lower shell 118. The upper shell116 can be separated from the lower shell through the use of a shelllatch release 120. The container 102 is sized and dimensioned to beplaced on a table or countertop to be easily accessible by a user. Incertain embodiments, the container 102 is approximately 7 inches tall, 4inches wide and 8.5 inches deep, but other dimensions of similarmagnitude to enable countertop placement are considered within the scopeof the present invention. The container 102 may be formed of plastic,metal, or other suitable material as well as any combination thereof. Incertain embodiments, such as seen here, a display 122 may also beprovided on the container 102 of the device 100. The display will bediscussed in more detail below. Other sizes and configuration will beapparent to one skilled in the art given the benefit of this disclosure.

FIG. 2 depicts the process of loading a stream of pill packets 110 intothe device 100. The upper shell 116 is separated from the lower shell118 by pressing the latch release 120 and sliding the upper shell 116back in relation to the lower shell 118. Once disengaged the upper shell116 can be removed providing access to the reservoir 108 in thecontainer 102. The stream of pill packets 110, here provided as a roll,can be loaded into the reservoir 108 and extraction channel 112, suchthat portion of a pill packet 114 extend out from container 102 thru theextraction channel 112. Once the stream of pill packets 110 is loaded,the upper shell 116 can be reattached to the lower shell 118 and thedevice 100 is ready for operation. In operation, pill packets 114 areextracted pulling on the portion of packet 114 extending from container102. When pulled, the pill packet 114, which is detachably connected tothe next pill packet in the stream of pill packets 110, pulls the streamof pill packets 110 from the reservoir 108, thru the extraction channel112, and out of the container 102 allowing the next pill packet 114 inthe stream of pill packets 110 to be available for extraction.

FIG. 3 provides an exploded view of the pill packet dosage trackingdevice 100. Illustrated are upper 116 and lower 118 shells of thecontainer 102 which encapsulates the stream of pill packets 110 loadedin the reservoir 108 and extraction channel 112 as well as the gate 104and controller 106. In this embodiment the display 122 is a LiquidCrystal Display (LCD) which has touch capability provided by acapacitive touch panel touch screen 124 placed over the LCD display 122.In other embodiments, controls such as buttons or switches may beprovided instead of touch screen capability. In certain embodiments, thedevice 100 may also be provided with a sensor 126, such as an opticalsensor or camera, for monitoring packets 114 as the pass thru theextraction channel 112. These elements will be discussed in more detailbelow.

In the example of FIG. 3, the gate 104 can be seen extending across theextraction channel 112 configured to move vertically to engage the pillpackets 114 of the stream of pill packets 110. FIG. 4 provides anexploded view where all the elements of the gate 104 can be seen. Theseelements include an inner slider 128, an outer slider 130, a motor 132and a linkage 134. The outer slider 130 is slidably coupled to the innerslider 128 and has an engagement edge 136 for engaging the pill packets114 of the stream of pill packets 110. The motor 132 is used to positionthe gate 104, not to advance or control the advance of the stream ofpill packets 110. The linkage 134 connects the motor 132 to the innerslider 128 and converts the rotational movement of the motor 132 to thelinear vertical movement of the gate 104. The inner slider 128, outerslider 130, and linkage 134 may be formed of plastic, metal, or othersuitable material as well as any combination thereof.

In certain embodiments, the gate 104 is mechanically biased in a closedposition by springs 138 between the inner slider 128 and outer slider130. In some embodiments, the gate 104 further includes a receiver 140configured to receive the engagement edge 136 of outer slider 130 whenthe gate 104 is in a closed position. The receiver 140 can be formed ofplastic, metal or other suitable material as well as any combinationthereof. In still other aspects, the engagement edge 136 of the outerslider 130 has an asymmetrical shape such as a guillotine bladeconfiguration optimized for the tearing properties of the pouch stream.

In some embodiments, the inner slider 128 as well as the outer slider130 are provided with magnets 142, 144 or other indicators that can beused in conjunction with sensors of the controller 106 to detect theposition of the inner slider 128 and outer slider 130. Magnet 142 isused to determine the position of the inner slider 128 and magnet 144 onthe outer slider 130 is used to determine the position of the outerslider 130.

The motor 132 is also controlled and monitored by the controller 106.FIG. 5 depicts one embodiment of controller 106 that can be used inconjunction with the device 100. The controller 106 of FIG. 5 is aprinted circuit board (PCB) configured, sized and dimensions to beplaced above the gate 104. In certain embodiments, the printed circuitboard is approximately 3 inches by 3 inches square. The controller 106includes a processor 146 and one or more sensors 148, 150. The processor146 is configured to monitor and control the gate 104 and thus theextraction of pill packets 114. In some embodiments, the processor 146keeps track of the amount and time of pill extraction. In some suchembodiments, the processor 146 of the controller 106 is responsible forallowing or preventing the extraction of a pill packet based on the timeof day, or amount of pill packets required to fulfill a dosage. In suchembodiments, the processor 146 may receive and store prescriptioninformation regarding the type and/or number of pills being administeredby the device 100 and control extraction accordingly.

The one or more sensors 148, 150, in this case Hall-Effect sensors, areconfigured to detect the position of the gate. A Hall-Effect sensor 148is configured to detect the magnet 142 on the inner slider 128 to, inconjunction with the processor 146, determine the position of the innerslider 128. The Hall-Effect sensor 150 is configured to detect themagnet 144 on the outer slider 130 to, in conjunction with the processor146, determine the position of the outer slider 130. Other possiblesensor and configurations will be apparent to one skilled in the art.

The controller 106 of FIG. 5 is also provided with a number of portsincluding an ethernet jack 152, Universal Serial Bus (USB) port 154, andSD card slot 156 that can be used to provide data to and from theprocessor 146. In some embodiments the controller 106 may also includewireless connectivity such as Bluetooth®, cellular, Wi-Fi®, RadioFrequency Identification (RFID), or any combination thereof of wirelesscommunication protocols and technologies. The controller 106 alsoincludes several connectors for connecting the processor 146 to otherdevices. The connectors include display connector 158 for driving thedisplay 122 of the device, and in embodiments with touch screencapability, receiving inputs from the touch screen 124; a motorconnector 160 for controlling the motor 132; and a sensor connector 162for connecting an optical sensor or camera. In certain embodiments asecondary processor 164 can be provided to add additional functionalityor processing.

FIG. 6 through FIG. 10 show the operation of the pill packet dosagetracking device 100. FIG. 6 is an exposed side view of the device 100showing the gate 104 in a biased closed position. FIG. 7 is an exposedside view of the device 100 showing the gate 104 transitioning to anopen position as a packet 114 passes through the gate. FIG. 8 is a frontview of the device 100 with parts made transparent to show theinteraction of the parts when the gate 104 is halfway in the transitionfrom a biased closed position to an open position. FIG. 9 is a frontview of the device 100 with parts made transparent to show theinteraction of the parts when the gate 104 has transitioned to a fullyan open position. FIG. 10 shows the operation of the Hall-Effect sensors148, 150 in determining the position of the gate 104.

The gate 104 is typically in a biased closed position as seen in FIG. 6and FIG. 8. In this state the inner slider 128 has moved linearlyvertically to be in close proximity to the controller 106 disposed abovethe gate 104. As discussed previously, the linear vertical movement ofthe gate is provided by the motor 132 and linkage 134 and is controlledby the processor 146 of the controller 106. Moving the inner slider 128to position this allows the outer slider 130 full vertical linearmovement in relation to the inner slider 128. Here the springs 138 biasthe outer slider 130 away from the inner slider toward the receiver 140,which is configured to receive the engagement edge 136 of the outerslider 130. In some embodiments, the device 100 identifies individualpill packets 114 mechanically by sensing the change in thickness of thepill packet 114 as it passes through the device 100. As a stream of pillpackets 110 passes thru the extraction channel 112 and under the gate104, the contained pill(s) push or otherwise wedge open the gate 104. Anexample of this can be seen in FIG. 7. FIG. 9 also shows the outerslider 130 halfway in the transition from the closed position to theopened position but without the individual pill packet 114 so as toprovide an unobstructed view of the engagement edge 136 of the outerslider 130. In certain embodiments, such as seen in FIG. 6 through FIG.9, the engagement edge 136 of the outer slider 130 has an asymmetricalshape, such as a guillotine blade shape. This aids in allowing the pillpacket 114 to push or wedge the outer slider 130 of the gate 104vertically linearly up and out of the way as the pill packet 114 ispulled out during extraction. The spring 138 or compliant mechanismreturns the outer slider 130 of the gate 104 to a closed position oncethe pill(s) have passed under. As seen in FIG. 10, one or more sensors,such as but not limited to an analog Hall-Effect sensors 148, 150,monitor the position of the inner slider 128 and outer slider 130 of thegate 104 over time to determine when a pill packet 114 passes under thegate 104. In the example of FIG. 6 through FIG. 10, magnet 142 of theinner slider 128 is detected by hall-effect sensor 148 on the controller106 and magnet 144 of the outer slider 130 is detected by hall-effectsensor 150 on the controller.

In some such embodiments, the device 100 can halt the stream of pillpackets 110 from being extracted from the device 100 to control dosing.In such cases, the stream of pill packets 110 is held securely betweenthe engagement surface 136 of the outer slider 130 of the gate 104 andreceiver 140. As discussed previously, the gate 104 is provided with amotor 132, allowing the gate 104 to be raised and lowered in response tosignaling from the processor 146 of the controller 106. As such, brakingis controlled by an on-board processor 146 or in some case in responsefrom an external processor, based on knowledge of dose and countingand/or identifying the pill packets 114 as they pass through the gate104, where pill packets 114 are presented to the user.

In some embodiments, the compliant nature of the gate 104 allows theuser to overpower the mechanism of the gate 104 in the case ofmechanical, power, electronic, software, or communication failure. Thisimproves patient safety and facilitates regulatory approval of thedevice 100.

In some embodiments, the device 100 can scan or identify markingsprinted on the pill packet 114 using a sensor 126, that makes use of anoptical scanner such as a photodetector, photodetector array, or camera166. In some cases, the markings on the pill packet 114 may behuman-readable, in which case an optical character recognition (OCR)method implemented by the processor 146 of the controller 106 may beemployed. In some cases, the markings maybe designed for computerreadability, such as barcodes, QR codes, AprilTags, or other visualfiducial marker. In some cases, these markings may be printed, etched,lasered, or molded. In other cases, these markings may be created bybonding reflective or nonreflective material to the pill packet 114, ormaterial that has otherwise different optical properties from thematerial of the stream of pill packets 110. The pill packets 114 mayalso be modified with hole punches or other mechanical features to alterthe flow of light through the pill packet 114.

In other embodiments, the device can scan or identify pill packets 114by automatic optical inspection of the medication contained therein. Bypackaging medication in clear pouches or packets 114, pharmacies canallow the device 100 to photograph the pill packet 114 using the camera166 and identify the medication contained therein by consulting adatabase of known medication images. This visual identification orverification can be used in conjunction with the mechanical tracking ofpill packets 114 to further ensure proper dosing.

As discussed previously, in some embodiments, the device can communicatedirectly with the Internet or other devices using Wi-Fi®, Bluetooth®Ethernet, and/or cellular connectivity, or other wireless communicationprotocol, to allow remote monitoring of when packets are consumed. Anexample of such connectivity can be seen in FIG. 11.

In the exemplary network of FIG. 11, the device 100 may be incommunication with one or more devices such as a personal electronic orcomputing device 168 such as a smart phone, tablet, or personalcomputer; a remote monitoring system or server 170; and a smart device172 such as a smart speaker, such as Amazon Echo™ or Google Home™. Thecommunication may be over the internet 174 or through direct device todevice communication 176 radio, Bluetooth®, or cellular communication,or the like. The personal electronic or computing device allow a user,either a patient or care-giver, to control and configure the operationof the device 100. Similarly, the device 100 can be controlled by theremote monitoring system or server 170 allowing hospitals, nursinghomes, or other care facilities fleet management of the device 100. Theremote monitoring system or server 170 may also be used by the device toconfirm medications and dosages provided by the pill packets 114. Inother embodiments, the personal electronic of computing system 168,remote monitoring system or server 170, or smart device 172 may performas or part of an authorization mechanism that prevent unauthorizedextraction of pill packets 114 from the device 100.

In some embodiments, dosing data are stored internally and retrievedmanually, e.g. by copying files to a USB flash drive. This allowsmonitoring even when Internet access is not available or desired.

In some embodiments, the device 100 has GPS and/or biometricauthentication used in concert with dosing data to control the gatedmechanism. This prevents the device 100 from releasing medication topeople other than the designated patient, or to prevent removal ofmedication outside the user's home. In some such embodiments, theprocessor 146 of the device 100 can communicate with the personalelectronic or computing device 168, such as smart phone, tablet, digitalassistant appliance, or computer, allowing the device 168 act as or partof an authorization mechanism to authenticate users with biometricrecognition (e.g., by fingerprint, facial or voice profile) or anability to transmit its GPS coordinates. In still other embodiments, thesmart device 170 may provide some or all of this functionality whenacting as an authorization mechanism.

In some embodiments, the display 122 of the device 100 provides a userinterface, in some embodiments having touch screens 124, which candisplay dosing schedules, present medication information, provide visualnotifications and reminders, and enable device provisioning, enrollment,and/or initial setup. The device 100 may also contain a microphoneand/or speaker for voice interaction. In certain embodiments thedisplay, microphone, and/or speaker may be provided by the personalelectronic or computing device 168 or the smart device 172 such as whenthe devices 168, 172 are acting as or part of an authorizationmechanism. The display 122 provides device configuration, user input,and visual feedback. the speaker provides auditory reminders and otherfeedback. the microphone allows for voice control.

For medications prescribed on an “As Needed” (PRN) basis (e.g., opioidsto be taken only with continuing pain at a designated time), a rollcontaining the controlled medication may be similarly pulled through,only after the patient indicates his need, for example, by pushing abutton on the touchscreen interface of the device. The need for such PRNdosing can thus be monitored by the prescriber.

To maintain health and reduce hospitalizations, it is essential thatnon-adherence be promptly detected, allowing intervention, especially bymedically trained associates of the patient's providers. Therefore, thedata-based system will promptly notify a designated clinician ofnon-adherence, so that instructions on omitted or late dosing can becommunicated to the patient.

FIG. 12 depicts an example electronic, computer, or computing device1000 that can be used to implement one or more aspects of the presentinvention, including control of the device 100 or personal electronic orcomputing device 168, remote monitoring system or server 170 or smartdevice 172. The functionality and hardware of such computing device 1000may be implemented in any of the electronic hardware systems orsubsystems described herein as involving or using a “computer” or“computing device” or the like, or related hardware for providing all orpart of the described functionality, provided as a separate device orintegrated into a system or subsystem described herein, as would beappreciated and understood by those of skill in the art. The terms“computer”, “computing device”, and the like utilized herein areintended to mean a processor at its most basic form, on up to morecomplex computing systems, including servers and cloud-based systems, inaccordance with conventional meanings of such terms. However, forpurpose of completeness, example components and related accessories thatare intended to be encompassed by the use of the terms “computer”,“computing device”, “processor”, and the like will be provided below inexample nonlimiting form.

The computing device 1000 is merely an illustrative example of asuitable computing environment and in no way limits the scope of thepresent invention. An “electronic device”, “remote device,” or “personalelectronic device” as represented in figures and description herein, caninclude a “workstation,” a “server,” a “laptop,” a “desktop,” a“hand-held device,” a “mobile device,” a “tablet computer,” a“processor,” or other computing devices, as would be understood by thoseof skill in the art. Given that the computing device 1000 is depictedfor illustrative purposes, embodiments of the present invention mayutilize any number of computing devices 1000 in any number of differentways to implement a single embodiment of the present invention.Accordingly, embodiments of the present invention are not limited to asingle computing device 1000, as would be appreciated by one with skillin the art, nor are they limited to a single type of implementation orconfiguration of the example computing device 1000.

The computing device 1000 can include a bus 1010 that can be coupled toone or more of the following illustrative components, directly orindirectly: a memory 1012, one or more processors 1014, one or morepresentation components 1016, input/output ports 1018, input/outputcomponents 1020, and a power supply 1024. One of skill in the art willappreciate that the bus 1010 can include one or more busses, such as anaddress bus, a data bus, or any combination thereof. One of skill in theart additionally will appreciate that, depending on the intendedapplications and uses of a particular embodiment, multiple of thesecomponents can be implemented by a single device. Similarly, in someinstances, a single component can be implemented by multiple devices. Assuch, the figures herein are merely illustrative of an exemplarycomputing device 1000 that can be used to implement one or moreembodiments of the present invention, and in no way limits theinvention.

The computing device 1000 can include or interact with a variety ofcomputer-readable media. For example, computer-readable media caninclude Random Access Memory (RAM); Read Only Memory (ROM);Electronically Erasable Programmable Read Only Memory (EEPROM); flashmemory or other memory technologies; CDROM, digital versatile disks(DVD) or other optical or holographic media; magnetic cassettes,magnetic tape, magnetic disk storage or other magnetic storage devicesthat can be used to encode information and can be accessed by thecomputing device 1000.

The memory 1012 can include computer-storage media in the form ofvolatile and/or nonvolatile memory. The memory 1012 may be removable,non-removable, or any combination thereof. Exemplary hardware devicesare devices such as hard drives, solid-state memory, optical-discdrives, and the like. The computing device 1000 can include one or moreprocessors that read data from components such as the memory 1012, thevarious I/O components 1020, etc. Presentation component(s) 1016 presentdata indications to a user or other device. Exemplary presentationcomponents include a display device, speaker, printing component,vibrating component, etc.

The I/O ports 1018 can enable the computing or electronic device 1000 tobe logically coupled to other devices, such as I/O components 1020. Someof the I/O components 1020 can be built into the computing device 1000.Examples of such I/O components 1020 include a sensor (including but notlimited to: weight sensor, infrared sensor, camera, chemical sensor,microphone, or the like), keypad, touchpad, joystick, recording orstorage device, game pad, satellite dish, scanner, printer, wirelessdevice, networking device, and the like, as appropriate.

Since suicidal ideation has been associated with the taking ofantidepressants and Anti-Epileptic Drugs, a virtual button on the device100 (or verbal request to Alexa) can indicate the need for immediatepsychiatric assistance for patients on such therapies.

Additional features of the device 100 of the present invention caninclude improved security. Specifically, devices can have Bluetooth®connectivity to the device 100 sensing a signal that the device isoperational (heartbeat). If the device 100 is taken outside a range ofthe controlling processor, the device locks and the monitoring networkis notified. Likewise, the device 100 can notify a monitoring networksuch as a remote monitoring system or server 170, if the device 100 isstolen, based on GPS coordinates or loss of network connectivity.

Anticipating FDA requirements for risk evaluation and mitigation, in theabsence of cellular connectivity, a virtual button on the device 100 cansignal by Bluetooth® connection to release an appropriate dose.

To any extent utilized herein, the terms “comprises” and “comprising”are intended to be construed as being inclusive, not exclusive. Asutilized herein, the terms “exemplary”, “example”, and “illustrative”,are intended to mean “serving as an example, instance, or illustration”and should not be construed as indicating, or not indicating, apreferred or advantageous configuration relative to otherconfigurations. As utilized herein, the terms “about” and“approximately” are intended to cover variations that may existing inthe upper and lower limits of the ranges of subjective or objectivevalues, such as variations in properties, parameters, sizes, anddimensions. In one non-limiting example, the terms “about” and“approximately” mean at, or plus 10 percent or less, or minus 10 percentor less. In one non-limiting example, the terms “about” and“approximately” mean sufficiently close to be deemed by one of skill inthe art in the relevant field to be included. As utilized herein, theterm “substantially” refers to the complete or nearly complete extend ordegree of an action, characteristic, property, state, structure, item,or result, as would be appreciated by one of skill in the art. Forexample, an object that is “substantially” circular would mean that theobject is either completely a circle to mathematically determinablelimits, or nearly a circle as would be recognized or understood by oneof skill in the art. The exact allowable degree of deviation fromabsolute completeness may in some instances depend on the specificcontext. However, in general, the nearness of completion will be so asto have the same overall result as if absolute and total completion wereachieved or obtained. The use of “substantially” is equally applicablewhen utilized in a negative connotation to refer to the complete or nearcomplete lack of an action, characteristic, property, state, structure,item, or result, as would be appreciated by one of skill in the art.

Numerous modifications and alternative embodiments of the presentinvention will be apparent to those skilled in the art in view of theforegoing description. Accordingly, this description is to be construedas illustrative only and is for the purpose of teaching those skilled inthe art the best mode for carrying out the present invention. Details ofthe structure may vary substantially without departing from the spiritof the present invention, and exclusive use of all modifications thatcome within the scope of the appended claims is reserved. Within thisspecification embodiments have been described in a way which enables aclear and concise specification to be written, but it is intended andwill be appreciated that embodiments may be variously combined orseparated without parting from the invention. It is intended that thepresent invention be limited only to the extent required by the appendedclaims and the applicable rules of law.

It is also to be understood that the following claims are to cover allgeneric and specific features of the invention described herein, and allstatements of the scope of the invention which, as a matter of language,might be said to fall therebetween.

What is claimed is:
 1. A pill packet dosage tracking device, the devicecomprising: a container comprising: a reservoir configured to hold astream of pill packets; and an extraction channel configured to guidepassage of the stream of pill packets from the reservoir out of thecontainer; a gate comprising: an inner slider; an outer slider slidablycoupled to the inner slider and having an engagement edge for engagingthe stream of pill packets; a motor for positioning the gate; and alinkage connecting the motor to the inner slider wherein the linkageconverts rotational movement of the motor to linear movement of thegate; wherein the gate is disposed in the extraction channel andvertically transitions between a closed position blocking extraction ofa pill packet of the stream of pill packets and an open positionallowing extraction of a pill packet; and a controller monitors theextraction of pill packets and controls the transition of the gatebetween the closed position and the open position.
 2. The device ofclaim 1, wherein the stream of pill packets comprises one or more packetof containing a predetermined dosage of pills wherein each pill packetis detachably connected to a next pill packet in the stream.
 3. Thedevice of claim 1, wherein the container further comprises an uppershell and a lower shell wherein removing the upper shell provides accessto the reservoir and extraction channel.
 4. The device of claim 1,wherein the gate is mechanically biased in a closed position by springsbetween the inner slider and outer slider.
 5. The device of claim 1,further comprising a receiver that receives the engagement edge of outerslider when the gate in a closed position.
 6. The device of claim 1,wherein the engagement edge of the outer slider has an asymmetricalshape.
 7. The device of claim 6, wherein the engagement edge has aguillotine blade configuration.
 8. The device of claim 1, whereinextracting a pill packet from the container through the extractionchannel causes the gate to transition from a closed position to an openposition, indicating to the controller that a pill packet has beenextracted.
 9. The device of claim 1, wherein the controller is maintainsa count of pill packet extracted from device.
 10. The device of claim 1,wherein the controller detects the extraction of one or more pillpackets corresponding to a timed dosage and lock the gate in a closedposition until a next timed dosage.
 11. The device of claim 1, whereinthe controller comprises: a processor that monitors and controls theextraction of pill packets; and one or more sensors that detect theposition of the gate.
 12. The device of claim 1, wherein the controllerfurther comprises wireless connectivity.
 13. The device of claim 12,wherein the device can be controlled remotely.
 14. The device of claim1, further comprising a display mounted on the container providing astatus of the device.
 15. The device of claim 14, wherein the displaycomprises a touch screen display.
 16. The device of claim 1, furthercomprising a sensor disposed along the extraction channel configured todetect a pill packet.
 17. The device of claim 16, wherein the sensorcomprises an optical scanner.
 18. The device of claim 16 wherein thesensor comprises a camera.
 19. The device of claim 1, further comprisingan authorization mechanism in communication with the controller.